Clincosm LogoSign in Get a demo

EMTM: Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice

Sponsor
Tabula Rasa HealthCare (Industry)
Overall Status
Completed
CT.gov ID
NCT02748148
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
5
Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify challenges and successes associated with implementing an enhanced medication therapy management service in primary care practice.

Condition or Disease Intervention/Treatment Phase
  • Other: Medication therapy management
 N/A

Detailed Description

The specific aim of this study is to implement a Medication Therapy Management (MTM) service in primary care that is enhanced by the incorporation of pharmacogenomics (PGx) and medication risk mitigation (MRM) factor technology and is standardized by a systematic approach to evidence- and personalized-based medicine. The primary objective is to implement the systematic approach to delivering an enhanced MTM service in a primary care setting. Secondary objectives include: determine how successful the communication between prescriber and pharmacist is within implementing the service, determine how PGx testing can be incorporated into primary care prescribers' daily work flow, determine if patients are receptive to PGx testing, determine how satisfied prescribers are with an enhanced MTM clinical service and their confidence to conduct on their own, and determine if enhanced MTM optimizes or changes drug therapy for patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Implementing an Enhanced Standardized Medication Therapy Management Approach Within a Primary Care Setting
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Medication therapy management

Medication therapy management service that is enhanced by the incorporation of pharmacogenomics and medication risk mitigation factor technology

Other: Medication therapy management
Implementation of a systematic approach to evidence- and personalized-based medicine through a pharmacist-guided medication therapy management service
Other Names:
  • Enhanced medication therapy management

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Qualitative description of process-related challenges and successes as assessed by observation and survey [3 months]

      Implementation

    Secondary Outcome Measures

    1. Quantitative description of bidirectional communication as assessed by turn-around times from pharmacist's recommendations delivered to prescriber's responses received [3 months]

      Communication

    2. Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey [3 months]

      Pharmacogenomic testing

    3. Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by survey [3 months]

      Prescriber survey

    4. Qualitative and quantitative description of potential impact of enhanced medication therapy management services on drug regimens as assessed by before-and-after observations [3 months]

      Impact

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Receiving primary health care from Elmwood Family Physicians; and

    • Medicare beneficiary; and

    • Currently prescribed at least 7 medications, or prescriber feels patient would benefit from enhanced medication therapy management, or actual or suspected medication-related problem

    Exclusion Criteria:

    • Not willing to participate in the study and sign informed consent; or

    • Non-English speaking or designated surrogate as translator not available

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Elmwood Family Physicians Marlton New Jersey United States 08053

    Sponsors and Collaborators

    • Tabula Rasa HealthCare

    Investigators

    • Principal Investigator: Kevin T Bain, PharmD, MPH, Tabula Rasa HealthCare

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tabula Rasa HealthCare
    ClinicalTrials.gov Identifier:
    NCT02748148
    Other Study ID Numbers:
    • MTM-309
    First Posted:
    Apr 22, 2016
    Last Update Posted:
    Oct 17, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Tabula Rasa HealthCare
    Medication Therapy Management
    Pharmacogenomics

    Study Results

    No Results Posted as of Oct 17, 2016